The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Bio-detek Tracerite Eeg Electrode.
| Device ID | K920264 |
| 510k Number | K920264 |
| Device Name: | BIO-DETEK TRACERITE EEG ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | BIO-DETEK, INC. 453 SOUTH MAIN ST., P.O. BOX 898 Attleboro, MA 02703 |
| Contact | Michael R Dupelle |
| Correspondent | Michael R Dupelle BIO-DETEK, INC. 453 SOUTH MAIN ST., P.O. BOX 898 Attleboro, MA 02703 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-21 |
| Decision Date | 1992-06-02 |